Techniques to Ensure High Quality Registration Dossiers Facilitate the Registration Procedure for Generics.
This Module provides a comprehensive description on the Common Technical Dossier structure — completely updated to reflect the latest changes in pharmaceutical regulatory affairs. The course is focusing on the specific regional EU requirements for Module 1 including discussion of the relevant legislation. The requirements for the Quality documentation (Module 2.3 & 3) will be presented in detail, taking into account the recent ICH-Q guidelines.
Organized by:
DIA
Invited Speakers:
Call contact
Deadline for Abstracts:
Call contact
Registration:
Fahd Khan, Manager Marketing & Program Development, DIA (India) Private Limited; Cell: +91-9223267327, Fax: +91-22-28594762, Email: Kanchan.patel@diaindia.org
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